Full Press Release Details
Oncolytics Biotech Inc. Announces
Phase 1b Study in Advanced Pancreatic Cancer
-- First Clinical Trial
Examining Effects of REOLYSIN
in Combination with a Checkpoint Inhibitor --
CALGARY, Oct. 20, 2015 /CNW/ - Oncolytics
Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that, following submission to the U.S. Food and
Drug Administration ("FDA") for review, the Investigational New Drug Application containing the protocol titled "A
Phase Ib study of pembrolizumab (KEYTRUDA ) in combination with REOLYSIN (pelareorep) and chemotherapy
in patients with advanced pancreatic adenocarcinoma" is now active.
"This is the first study examining the
effects of REOLYSIN in combination with a checkpoint inhibitor in human patients," said Dr. Brad Thompson,
President and CEO of Oncolytics. "It builds on our previous clinical work in pancreatic cancer as well as findings from multiple
clinical and preclinical studies indicating that REOLYSIN can upregulate PD-1 and PD-L1."
The study will enroll patients 18 years or
older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first
line treatment. It is an open-label Phase Ib trial designed to determine the safety and dose-limiting toxicities of REOLYSIN
and chemotherapy (gemcitabine or irinotecan or fluorouracil, at the treating physician's preference) in combination with pembrolizumab.
Secondary endpoints include overall response rate and progression free survival by immune-related response criteria; overall survival;
and effects of REOLYSIN and pembrolizumab when administered in combination as determined by analysis of pre- and
post-treatment treatment biopsies and blood based immune markers. Following an initial six to nine patient safety run-in, up to
an additional 15 patients may be enrolled for further evaluation of safety and efficacy.
Oncolytics has previously conducted other clinical
studies in pancreatic cancer. Mostly notably, in July 2015, the Company reported final data from a Phase 2 single-arm clinical
trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar ) in
chemotherapy-na ve patients with advanced or metastatic pancreatic cancer (REO 017). The reported data suggested that this
drug combination, when compared to gemcitabine alone (as seen in historical data), can increase median overall survival, as well
as generate an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates. The
Company has received Orphan Drug Designation from the FDA and the European Medicines Agency for the use of REOLYSIN
in the treatment of pancreatic cancer.
About Pancreatic Cancer
The American Cancer Society estimates that 48,960 Americans will be diagnosed with pancreatic cancer and an estimated 40,560 Americans
will die from the disease in 2015. Approximately 44,539 patients are affected with pancreatic cancer at any time in the United
States. The prognosis for patients diagnosed with pancreatic cancer, regardless of stage, is generally poor; the relative five-year
survival rate for all stages combined is approximately seven percent.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.
Oncolytics' clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN ,
its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking
statements within the meaning of the U.S. Securities Act of 1933, as amended, and U.S. Securities Exchange Act of 1934, as amended,
and forward-looking information within the meaning of Canadian securities laws. Statements, other than statements of historical
facts, included in this press release that address activities, events or developments that Oncolytics expects or anticipates will
or may occur in the future, including such things as, the Company's expectations related to the phase 1B study in pancreatic cancer
patients with advanced pancreatic adenocarcinoma, the Company's belief as to the potential of REOLYSIN as a cancer
therapeutic, and other such matters are forward-looking statements and forward-looking information and involve known and
unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking
statements and forward-looking information. Such risks and uncertainties include, among others, risks related to the statistical
sufficiency of patient enrollment numbers in separate patient groups, the availability of funds and resources to pursue research
and development projects, the efficacy of REOLYSIN as a cancer treatment, the tolerability of REOLYSIN
outside a controlled test, the success and timely completion of clinical studies and trials, the Company's ability to successfully
commercialize REOLYSIN , uncertainties related to the research and development of pharmaceuticals and uncertainties
related to the regulatory process. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S.
securities commissions for additional information on risks and uncertainties relating to the forward-looking statements and forward-looking
information. Investors are cautioned against placing undue reliance on forward-looking statements and forward-looking information.
The Company does not undertake to update these forward-looking statements and forward-looking information, except as required by
SOURCE Oncolytics Biotech Inc.
For further information: NATIONAL Equicom, Nick Hurst, 800
6th Ave. SW, Suite 1600, Calgary, Alberta T2P 3G3, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@national.ca; NATIONAL Equicom,
Michael Moore, San Diego, CA, Tel: 858.886.7813, mmoore@national.ca; Dian Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd
Floor, New York, NY 10018, Tel: 212.825.3210, Fax: 212.825.3229, sforman@dgicomm.com
CO: Oncolytics Biotech Inc.
CNW 06:30e 20-OCT-15